CBD Draws FDA Crackdown and WHO Attention

CBD, the non-psychoactive compound in cannabis and hemp that’s drawn much interest and shown great promise in the treatment of medical conditions ranging from pain to brain cancer, is being put to truth-in-marketing evidence tests as international drug regulators are considering how to control the cannabinoid.  

Last week, the U.S. Food and Drug Administration warned companies whose hemp-derived products contain cannabidiol against making unsubstantiated claims that their CBD products can cure cancer.

This week, a leading medical publication revealed that more than two-thirds of hemp-derived CBD products purchased online by researchers were incorrectly labeled and that one-fifth contained THC despite manufacturers’ claims their products do not contain the psychoactive cannabinoid.

Both headlines arise as the World Health Organization hears testimony about whether CBD, derived from hemp or its botanical cousin cannabis, should be governed by the 1971 Convention on Psychotropic Substances.

In the United States, the agency responsible for policing the American food and drug market last week sent warning letters to four companies it says are "illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these outcomes." The FDA is targeting more than two dozen products containing CBD, which, the agency noted, “is not FDA approved in any drug product for any indication."

The products include oil extracts, syrups and topicals. Warning letters were sent to Greenroads Health, Natural Alchemist, That's Natural! Marketing & Consulting and Stanley Brothers Social Enterprises LLC (whose brands include the popular CW Hemp line).

Although claims vary from product to product, the FDA said  fraudulent cancer products "often use a particular vocabulary." The agency identified these phrases as the most common red flags:

  • Treats all forms of cancer

  • Miraculously kills cancer cells and tumors

  • Shrinks malignant tumors

  • Selectively kills cancer cells

  • More effective than chemotherapy

  • Attacks cancer cells, leaving healthy cells intact

  • Cures cancer

 

Concern Over Cancer Claims

The FDA has grown increasingly concerned at the proliferation of products claiming to treat or cure serious diseases like cancer. The FDA sent similar letters to more than a dozen companies in 2015 and 2016. But the latest warnings are notable in that they target one of the biggest players in the hemp-derived CBD market -- Stanley Brothers, whose best-known CBD product is Charlotte’s Web, an extract popularized by a young Colorado girl suffering from epilepsy who who experienced a dramatic reduction in seizures after she used Stanley Brothers’ cannabis oil extract.

Stanley Brothers said in a statement, "We take regulatory compliance very seriously. Our customers love to share their very personal stories about how our products helped improve their lives or those of their loved ones. ... We will work with the FDA to ensure that we better monitor how we share third-party testimonials."

There are more than 200 brands of hemp-derived CBD, according to a report from the Brightfield Group. The market is estimated to be worth about $287 million this year and is expected to hit $1 billion by 2020.

CBD oil derived from hemp is now commonly available nationwide via web sites and mail order services. Those operations survive on the assumption that cannabidiol products below the legal threshold for THC percentage in hemp (0.3 percent or less) are technically legal.

Some CBD producers appear to be hoping that marketing their products as dietary supplements would help them escape FDA scrutiny. CW Hemp has this disclaimer on its website: "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease." 

The government disagrees.  

"The claims on your websites establish that the products are drugs," read the agency's letter to Stanley Brothers/CW Hemp CEO Joel Stanley. "They are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or any function of the body."

An FDA spokesman said the agency wants to ensure medical claims are backed by evidence.

“We recognize that there is interest in developing therapies from marijuana and its components,” Michael Felberbaum told Marijuana Business Daily. “We continue to assess whether there are appropriate and effective therapeutic uses of marijuana and its components and believe the drug approval process … is the most appropriate way for this to occur.”

For a study published this week by the Journal of the American Medical Association researchers bought 84 hemp-derived CBD products online and had them tested in multiple labs. The findings:

  • About 43% contained more CBD than the label claimed.

  • About 26% contained less CBD than promised.

  • About 31% were within 10 percentage points of the promise.

 

Careful Not to Cross the Line

As a company that has pioneered true cannabis-derived CBD in a legal medicinal cannabis state since 2009, Constance Therapeutics strives to abide by the federal regulatory framework and produces its products from cannabis-derived cannabinoids. Numerous studies have shown CBD to be particularly effective in synergy with THC.

“Cannabis bears a heavy burden on an un-level playing field,” said company founder Constance Finley. “It's tempting to want to share outside approved boxes, because cannabis isn't allowed to play in the approved boxes/spaces easily. But we know and respect the dangers.”

Finley said Constance Therapeutics is very careful to not cross the line.

“As CBD becomes a panacea, we refused to sell it alone for oncology patients because we do not see evidence that CBD alone would help,” Finley said. “We have held ourselves to the highest standards while not being able to make any claims. This is the tough real world of playing in a medicinal space.”